This is a single center, open-label, nonrandomized, phase 1b study of TRC105 in combination with standard dose treatment in patients with stage IV non-squamous non-small cell lung cancer.
Advanced non-small cell lung cancer has been historically difficult to treat, and novel agents are in dire need.TRC105 has been shown to enhance the anti-angiogenic effect of bevacizumab and may result in more effective angiogenesis inhibition and improved clinical efficacy when combined with bevacizumab and paclitaxel/carboplatin. Participants will be treated with the combination drugs for 6 cycles of therapy (3 weeks per cycle) and may or may not be placed on maintenance therapy depending upon the induction response. Maintenance therapy will continue until there is disease progression, unacceptable toxicity, or patient withdrawal. Blood collections and tumor assessments will be performed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Each patient will be dosed with 6, 8, or 10 mg/kg of TRC105 up to a maximum dose of 850 mg for women and 1,000 mg for men based upon overall body weight.
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Number of patients with a change in medical management
Adverse events will be graded using the NCI Common Terminology for Criteria for Adverse Events(CTCAE). Incidence, timing, and relatedness of adverse events will be considered as factors in the change of a patient's medical management.
Time frame: Baseline up to 28 days after the last cycle
Measurement of tumor response
Radiological tumor assessments from CT or MRI scans will be used to determine an objective response rate.
Time frame: Baseline to 3 years
Progression-free survival
Time to progressive disease
Time frame: Baseline to 3 years
Number of patients with progression-free survival at 6 months
The percentage of patients with progression-free survival in the study
Time frame: 6 months after the last cycle of treatment completed
Overall survival
Length of patient survival after starting study treatment
Time frame: Baseline to 3 years
Measurement of TRC105 concentrations
Serum TRC105 concentrations will be measured using validated enzyme-linked immunoassay testing that will assist in analyzing the pharmacokinetics of the drug.
Time frame: Collected approximately every 63 days (3 cycles)
Measurement of TRC105 anti-product antibodies
Anti-product antibody concentrations will be measured using validated enzyme-linked immunoassay testing that will assist in analyzing immunogenicity.
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Time frame: Collected approximately every 63 days (3 cycles)
Identify angiogenic protein biomarkers
A central reference lab will conduct biomarker testing that will assist in the analysis of the pharmacodynamics effects on circulating angiogenic biomarkers.
Time frame: Collected approximately every 63 days (3 cycles)